Compensatory Behavior of E-cig Users in Response to Reduced Nicotine E-liquids

Completed · Early Phase 1

Conditions studied: Healthy, Nicotine Addiction, Electronic Cigarette Use

In brief

The goal of this clinical trial is to learn if low nicotine eliquids work to reduce exposure to nicotine, in addicted ecig users, without increasing consumption of other harmful constituents. The main questions it aims to answer are: * Does switching to lower nicotine eliquids change the vaping behavior of addicted ecig users? * Does switching to lower nicotine eliquids reduce the amount of nicotine consumed? Researchers will compare ecig users who switch from a higher to lower nicotine eliquid to a control group that does not switch. Participants will: * Complete history of tobacco use and nicotine addiction questionnaires * Switch from higher to lower nicotine product or control for 15 days * Complete daily questionnaires to report craving, mood and nicotine withdraw For one full day under each nicotine condition, participants will: * record puffing behavior using a topography monitor * wear a sensorized shirt that measures the depth and duration of inhalation, and * collect a saliva sample at the end of each day

Key facts

Study ID

NCT06602492

Run by

Rochester Institute of Technology

People needed

72

Starts

2021-07-15

Expected to finish

2023-11-15

Last updated by the study team

2024-09-27

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21 years or older
• Regular 30-day e-cig users

You may not qualify if…

• Intention to quit using e-cigs within the next 30 days
• Use of other tobacco products in addition to e-cigs on more than 9 of the previous 30 days
• History of acute or chronic asthma
• Previous diagnosis of cancer
• Other chronic medical conditions
• Use of chronic prescription medications
• Pneumonia in prior six weeks
• Upper respiratory tract infection or other febrile illness in previous 2 weeks
• Smokers on antioxidants, or anti-inflammatory therapy
• Pregnant women or women who intend to become pregnant or breast-feeding
• Had Covid-19 in the past 2 months or still feeling effects from a Covid-19 illness

Where it is running

• Rochester Institute of Technology — Rochester, New York, United States

Full record on ClinicalTrials.gov

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